Submission Details
| 510(k) Number | K233810 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 30, 2023 |
| Decision Date | April 25, 2024 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Portrait VSM
Apr 2024
Decision
147d
Days
Class 2
Risk
About This 510(k) Submission
K233810 is an FDA 510(k) clearance for the Portrait VSM, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on April 25, 2024, 147 days after receiving the submission on November 30, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.
Device Classification
| Product Code | MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2300 |
Manufacturer
Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI · US
Jung William
31 submissions
31 cleared
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